Table 1.
Definition of programme theory, with illustrative data
| Domain | Theme | Definition | Illustrative Quote |
|---|---|---|---|
| Context | |||
| Trial set-up | The support received before the trial starts allows mentees to develop the necessary VR skills and identify potential barriers arising during trial set-up. | “Both [Trial Manager] and mentor 3 reported that the funding in [research site] had been pulled due to changes in the excess treatment costs process. I reported that [Trial Manager] had said the situation is being escalated internally to try and identify a means to fund the study. Unfortunately, there is nothing we can do at the moment.” [Emails_December_2018; Mentor 1] | |
| Ongoing mentoring | The interactions between mentors, mentees, members of the research team, and trial sites that occur throughout the study duration. | “I think it’s just – we’ve got the manual, but the reality is, there’s not one participant that’s going to prescriptively follow it, so it’s all the nuance in how to work with specific workplace context. So, it may be to do with – well, even things like the legal aspect of things, about reasonable adjustments or finding – just getting feedback on what you’re doing and knowing you’re doing the right thing.” [Interview OT 5] | |
| Mechanism | |||
| Collective understanding | Developing a collective understanding of the mentees as RETAKE intervention OTs, ensuring they understand their responsibilities, study procedures, and differentiate their usual NHS role from the RETAKE role. | “During mentoring, I did talk about triaging participants if you feel overloaded as opposed to decreasing or stopping recruitment. Recruitment is of vital importance to the study. We want you to telephone the participant within 48 hours as this is the EARLY bit [of the intervention]” [Emails_June2019- Mentor 1] | |
| Monitoring | Providing longer-term support and responding to changing needs. Offering feedback on mentees’ adherence to research processes and intervention delivery. | “[In mentoring] I said that other OTs were sending me letters to check and they [mentees] were welcome to do that. [Mentee] said she had started writing letters to her participants since the training and feels it …helps everyone “to be on the same page”. [Email_Dec2018; Mentor 3] | |
| Timely support | Providing support when or before a problem appears (e.g., identifying alternative OTs if a site cannot cope with demand). | “I just used the mentoring then to kind of go over everything to think well okay, I am doing this correctly or what do I need to do? … There are a couple of times where I have had to get support really, really quickly and that has never been a problem as well, so emergency help as well.” [Interview OT 1] | |
| Positive reinforcement | Mentees are positively encouraged when they are delivering the intervention as intended and demonstrating command of VR (e.g., good clinical decision making). They are also supported when they experience challenges with trial procedures and reminded that it is okay to have difficulties. |
“I think most of us probably don’t have… are not working with patients returning back to work all the time so I think sometimes you are not always 100% sure of yourself and what you are doing.” [Interview, OT 36] ‘And she [mentor] would check letters and things before we sent them out to make sure we were on the right lines with things and give us some tips for writing them initially.’ [Interview, OT 8] |
|
| Reflective practice | Mentor or mentees’ ability to think about evaluate and implement trial processes and procedures, and act based on their previous experiences. | ‘But she [OT mentor] did it in a way where she would sort of help us to answer the question rather than just telling us the answer, so she would make us think about it.’ [Interview OT 8] | |
| Support data completeness | Supporting completion of case report forms, study documentation and reviewing letter-writing standards for documenting trial intervention delivery. | “Hi [mentor 3], Sorry I have another question. On form 22 which is the session content form, I am wondering what to do with the graded return to work with my participant. As he is self-employed, do I tick RTW without direct employer contact?” [Email_September_2018 Mentee 10] | |
| Facilitation strategy | Mentors find and connect mentees with key stakeholders based on the identified problem. | “I will ask [mentor 1] to liaise with and advise the OTs. So long as they manage the list and prioritise within it, this shouldn’t be a problem. Hopefully, the intervention allocation will change, and the waiting list will then be reduced. There could then be a period where hardly anyone is allocated to the intervention and pressures will ease. Please let me know who I can talk to regarding the service development. If it does go ahead my big ask would be not to deliver VR to people randomised to usual care who have consented to participate in the trial.” [Emails_June_2019; Research Team – CI] | |
| Shared learning experience | Mentors share their experience and best practice. Mentees generate a peer support group that improves their self-efficacy. | “Mentor 1 kindly presented a case study. A man who was in hospital Sat-Thurs, she contacted him the day he left hospital and saw him a week later. He returned to work on the Monday after discharge as money was an issue. She persuaded [him] to take another week of sick, wrote a sick note and met with his employer. She has planned a GRTW and mentees 3 and 4 asked if mentor could share the letter to employer as they are keen to learn.” [Emails_Sept_2018; Mentor 1] | |
| Managing research and clinical duties | Mentees learn to manage the trial intervention delivery and administrative burden of the project alongside their usual clinical tasks and responsibilities. | “Just to confirm that you told me you are doing all of the screening and recruitment of participants as well as holding a caseload for RETAKE. Plus you still have all your usual NHS responsibilities, which are also huge. L, the research nurse is doing some screening but not to the detail you are and she also as 6 other trials, so it sounds like she cannot do anymore to assist you. If you need us to approach L and support her in any way, we can.” [Emails_Sept_2028; Mentor – 5] | |
| Outcome | |||
| Increased mentee confidence | Mentees developed research and clinical (i.e., vocational rehabilitation) skills that allowed them to trust their ability to fulfil their role as a RETAKE OT. | “I have seen my first patient for an initial assessment. Just wanted to check I’m doing the right things, and ask a few questions.” [Emails_January_2020; Mentee 3] | |
| Intervention delivered with fidelity | The intervention was delivered as intended. Mentees delivering the intervention accurately and improved the recording of the support provided. | “I think they – firstly, I think they’re there to monitor and check that we’re actually delivering the intervention. I think it’s to ensure that we’re – for the research, we’re doing what we should be doing.” [Interview, OT 5] | |
| Reduced contamination | Mentees and the research team were able to identify instances when changes in services, staffing and new research studies might lead to changes in the outcomes of interest in the trial, therefore identifying risk of contamination. | “Dear all, please see this email below…It seems there is another study wanting RTW participants in [city]. I do not think we have any sites in West Midlands. But it is yet another potential factor affecting results in [city] so needs recording as a potential contamination” [Emails_July_2019; Email between mentors and CI] | |
OT: Occupational therapist; RTW: Return to work; CI: Chief Investigator; MRF: Mentoring record form